Job Summary
The Technical Program Manager coordinates the development of a medical device across hardware, optics, software, imaging, systems engineering, quality, regulatory, clinical and manufacturing workstreams. The role owns the integrated program plan and the engineering operations processes that support development, testing and early manufacturing, including bills of materials, configuration records, inventory and purchasing coordination, and support for design controls and the design history file. Engineering and functional leads retain ownership of technical decisions, with quality and regulatory leads overseeing applicable requirements, while the Technical Program Manager keeps reliable records, coordinates review and approval workflows, surfaces issues early and drives open items to closure. This is a full-time role that may be performed remotely with substantial overlap with Eastern Time, and it requires travel to the company's US office about once a quarter, with additional travel around critical milestones.
Key Responsibilities
- Maintain the integrated development plan and translate objectives into realistic milestones, deliverables, owners, dependencies, resource needs and target dates through verification, regulatory submission and manufacturing transfer.
- Lead recurring meetings and milestone reviews, document decisions, maintain risk and action logs, and drive cross-functional blockers and open items to closure.
- Coordinate prototype builds, integration, software releases, test campaigns, and laboratory, cadaver or clinical activities, including materials, configurations, contractor deliverables, external bookings and readiness reviews.
- Maintain development and released bills of materials, including part numbers, revisions, quantities, supplier information and links to specifications and drawings, in partnership with engineering leads.
- Coordinate approved engineering changes and assess their impact on schedules, suppliers, inventory, testing, risks and documentation.
- Maintain records of build configurations, software versions and approved deviations.
- Track stock quantities, locations, allocations, open orders, shortages and replenishment needs, and work with on-site staff to record receiving, consumption, stock movements and inventory checks.
- Coordinate quotations, purchase requests, orders and supplier follow-up within approved budgets, monitor lead times and delivery commitments, and escalate material risks.
- Partner with engineering, quality and regulatory leads to maintain design and development records, coordinate design reviews, track missing documentation, and maintain traceability from requirements and risk controls to test evidence.
- Support controlled-document and approval workflows, training records, and follow-up on assigned quality actions under the direction of quality and regulatory leads.
- Maintain practical dashboards and processes, and provide concise leadership updates on progress, critical-path activities, resource constraints, risks, material readiness and decisions needed.
- Coordinate closely with on-site staff on inventory and build records.
Qualifications
- 5-10 years of experience in technical program management, engineering operations, systems engineering, product development or a related role.
- A degree in engineering, science or another technical field is preferred.
- Experience managing multidisciplinary hardware and software products and integrated schedules involving technical dependencies, suppliers, contractors and testing.
- Hands-on experience with bills of materials, configuration and change control, inventory tracking, purchasing coordination and material planning for prototype or early-production builds.
- Strong technical fluency and communication skills, with the ability to lead technical discussions, document decisions clearly, challenge assumptions, identify risks and hold contributors accountable while respecting technical ownership.
- Highly organized, detail-oriented and pragmatic, with the ability to establish effective processes and work independently in a remote role while coordinating with on-site staff.
- Experience with program management, PLM, QMS or inventory tools such as Jira, Confluence, Smartsheet, Asana, Arena, OpenBOM or equivalent platforms.
- Strong integrity, high agency, and clear and direct communication across engineering, clinical, quality, regulatory, operations, leadership, partner and customer audiences.
- Curiosity, practical judgment, comfort with ambiguity, low ego, urgency and discretion.
- Experience taking Class II medical devices or other FDA-regulated products from prototype development through verification, regulatory submission and manufacturing transfer is preferred.
- Familiarity with design controls, design history files, verification and validation, risk management, and standards such as ISO 13485, ISO 14971, IEC 62304 or IEC 60601 is preferred.
- Experience with supplier controls, purchasing documentation, manufacturing bills of materials, assembly records, and component or unit traceability is preferred.
- Experience with surgical imaging, endoscopy, robotics, computer vision, optical systems or time-of-flight sensing, particularly in an early-stage startup or small technical team, is preferred.